Device Classification Name |
instrument, vitreous aspiration and cutting, ac-powered
|
510(k) Number |
K950852 |
Device Name |
CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP) |
Applicant |
H.S. INTL. CO., INC. |
5040 COMMERCIAL CIRCLE, UNIT A |
CONCORD,
CA
94520
|
|
Applicant Contact |
HENRY SHAPIRO |
Correspondent |
H.S. INTL. CO., INC. |
5040 COMMERCIAL CIRCLE, UNIT A |
CONCORD,
CA
94520
|
|
Correspondent Contact |
HENRY SHAPIRO |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 02/27/1995 |
Decision Date | 05/19/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|